Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Calcitriol and Docetaxel in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed Over 18 NCI OHSU-GIM-02007-L OHSU-1104, NCT00238199

Objectives

Primary

1. Determine the time to progression in patients with metastatic or locally advanced pancreatic cancer treated with calcitriol and docetaxel.

Secondary

1. Determine the median and one-year survival of patients treated with this regimen.
2. Determine the overall response in patients treated with this regimen.
3. Determine the toxic effects of this regimen in these patients.
4. Determine the change in pancreatic cancer-induced pain in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Diagnosis of pancreatic cancer
  • Locally advanced or metastatic disease

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for metastatic disease
• No prior chemoradiotherapy for locally advanced disease
• No prior adjuvant docetaxel
  • Other prior adjuvant chemotherapy allowed

Endocrine therapy

• Not specified

Radiotherapy

• See Chemotherapy
• More than 2 weeks since prior radiotherapy

Surgery

• More than 30 days since prior investigational surgery

Other

• More than 7 days since prior and no concurrent digoxin or thiazide diuretic therapy
• More than 30 days since prior investigational therapy
• No concurrent magnesium-containing antacids, bile resin-binding drugs, or calcium supplements

Patient Characteristics:

Age

• Over 18

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC > 3,000/mm³
• Absolute neutrophil count > 1,500/mm³
• Platelet count > 100,000/mm³
• Hemoglobin ≥ 8.0 g/dL (transfusion allowed)

Hepatic

• Bilirubin < 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase (AP) < 5.0 times ULN
• ALT and AST < 2.5 times ULN (if AP < 2.5 times ULN)

  OR

• ALT and AST < 1.5 times ULN (if AP > 2.5 times ULN and < 5.0 times ULN)

Renal

• Creatinine < 1.3 mg/dL
• Calcium < 10.5 mg/dL
• Phosphate < 4.7 mg/dL
• No kidney stones within the past 5 years
• No history of hypercalcemia

Cardiovascular

• No myocardial infarction within the past 3 months
• No uncontrolled heart failure with a known ejection fraction < 30%
• No other significant heart disease

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
• No peripheral neuropathy ≥ grade 2
• No comorbid condition that would preclude study participation

Expected Enrollment

A total of 40 patients will be accrued for this study.

Outcomes

Time to progression

Median and one-year survival
Overall response
Toxicity
Change in pancreatic cancer-induced pain

Outline

Patients receive oral calcitriol on days 1, 8, and 15 and docetaxel IV over 15-30 minutes on days 2, 9, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Trial Contact Information

Trial Lead Organizations

Oregon Health and Science University Cancer Institute

Charles Blanke, MD, FACP, Principal investigator		Ph: 503-494-1556; 800-494-1234

Registry Information
Official Title		Phase II Study of Calcitriol-Enhanced Docetaxel in Patients with Previously Untreated Metastatic or Locally Advanced Pancreatic Cancer
Trial Start Date		2002-06-03
Trial Completion Date		2006-08-31
Registered in ClinicalTrials.gov		NCT00238199
Date Submitted to PDQ		2005-08-11
Information Last Verified		2006-08-15
NCI Grant/Contract Number		CA69533

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